Catheter for use with an endoscope

ABSTRACT

Endoscopes, medical devices for use with endoscopes, and methods for making and using endoscopes. An example medical device for use with an endoscope is a catheter having one or more ridges formed on an outer surface thereof. The ridges may interact, for example, with the elevator of an endoscope.

FIELD

The present invention pertains to endoscopes and medical devices for usewith endoscopes. More particularly, the present invention pertains toendoscopic catheters with one or more ridges or protrusions formedthereon.

BACKGROUND

A wide variety of endoscopes, medical devices for use with endoscopes,and endoscopic procedures have been developed. Of the known endoscopes,medical devices for use with endoscopes, and endoscopic procedures, eachhas certain advantages and disadvantages. There is an ongoing need toprovide alternative endoscopes as well as methods for making and usingendoscopes.

SUMMARY

The invention provides design, material, and manufacturing methodalternatives for endoscopes, medical devices for use with endoscopes,and for methods for making and using medical devices and/or endoscopes.An example medical device for use with an endoscope is a catheter havingone or more ridges or protrusions formed thereon at desired locationsalong the catheter shaft. The ridges or protrusions may interact, forexample, with the elevator of an endoscope. Some additional detailsregarding these and other embodiments are described in more detailbelow.

The above summary is not intended to describe each disclosed embodimentor every implementation of the present disclosure. The Figures andDetailed Description which follow more particularly exemplify theseembodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description of various embodiments of the disclosurein connection with the accompanying drawings, in which:

FIG. 1 is a schematic plan view of an illustrative endoscopic instrumentassembly;

FIG. 2 is a perspective view of an illustrative medical device disposedin the working channel of an illustrative endoscope;

FIG. 2A is a cross-sectional view of another illustrative medical devicedisposed adjacent an illustrative elevator;

FIG. 3 is a side elevation view of the illustrative medical device shownFIG. 2 engaged with an elevator;

FIG. 4 is a side elevation view of the movement of the elevator relativeto the illustrative medical device;

FIG. 4A is a side elevation view of another illustrative medical device;

FIG. 4B is a side elevation view of another illustrative medical device;

FIG. 5 is a side elevation view of another illustrative medical device;

FIG. 6 is a side elevation view of another illustrative medical deviceengaged with an elevator; and

FIG. 7 is a side elevation view of the medical device shown in FIG. 6where the elevator is activated so as to activate the medical device.

DETAILED DESCRIPTION

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

A vast number of endoscopic devices exist that have a wide variety ofapplications. In at least some applications, the position of theendoscopic device and/or the position of a particular medical devicedisposed in the endoscopic device is important. This is because it maybe challenging to precisely navigate the endoscope or endoscopicinstruments through the anatomy of a patient. For example, whenendoscopes are used for biliary applications, it may be difficult toadvance an endoscopic medical device through the papilla of Vater andtoward the bile duct as it exits the working channel of the endoscope.Moreover, once a device is successfully advanced through the papilla ofVater, subtle movement of the device can result in the device beingwithdrawn back out from the papilla of Vater, necessitating anotherround of skilled maneuvering in order to proceed with the intervention.

When dealing with the position of a guidewire, a number of proximal“wire locks” have been developed that are disposed near the proximalhandle of the endoscope. There is an ongoing need for improved devicesfor securing the position of guidewires within the working channel of anendoscope.

For at least some of the same reasons that are desirable to control theposition of a guidewire, controlling the position of a catheter disposedin the working channel of an endoscope may be also desirable. Inaddition, it may be desirable to hold, advance, and retract a catheterin a controlled manner for a number of different interventions.

FIG. 1 is an example endoscopic instrument assembly 10 that addresses atleast some of these needs as well as provides a number of additionaldesirable features. Assembly 10 includes an endoscope 12 having a shaftportion 14 and a handle portion 16. Shaft portion 14 includes a distalend region 18 and a distal port 20 (best seen in FIG. 2) where one ormore medical devices (e.g., a guidewire 22 and/or a catheter 24) aredisposed within a working channel 26 (best seen in FIG. 2) formed inshaft portion 14 with medical devices capable of extending distally fromdistal port 20. An elevator 36 can be disposed adjacent port 20 thatwhen actuated alters the angle at which guidewire 22 and/or catheter 24exits port 20. Handle portion 16 includes one or more openings or acontrol region 28 where instruments (e.g., endoscopic instruments,guidewires, catheters, and the like) can gain access to working channel26 and be extended through shaft portion 14 and out from port 20.Control region 28 may also include a control wire (not shown) forcontrolling elevator 36.

For the reasons stated above, it may be desirable for assembly 10 toinclude one or more features or a plurality of features that allow auser to hold, advance, and retract a catheter disposed in workingchannel 26. Turning now to FIG. 2, it can be seen that catheter 24includes one or more protrusions, ribs or ridges 40 disposed at thedistal end region 38 of catheter 24. Ridges 40 project outward fromcatheter 24 and are spaced so that elevator 36 can fit between adjacentridges 40 when elevator 36 is actuated as depicted in FIG. 3. Because ofthe arrangement of ridges 40, actuating elevator 36 so that it isdisposed between adjacent ridges 40 holds the position of catheter 24within working channel 26. The ridges or ribs 40 can be any useful formthat can engage the actuating elevator, as desired.

Elevator 36 can also include a number of features that contribute to thecontrol of catheter 24. For example, elevator 36 includes a notch 42formed therein that is designed to improve the fit between catheter 24and elevator 36. More particularly, notch 42 is shaped so that elevator36 can more securely contact and hold catheter 24 in place. In someembodiments, notch 42 also allows elevator 36 to be actuated againstguidewire 22 so that guidewire 22 can be secured between elevator 38 andthe wall of shaft portion 18. Thus in some embodiments, elevator 38 isdesigned with the ability to secure the position of catheter 24 andguidewire 22.

The shape or configuration of notch 42 (i.e., the shape of elevator 36adjacent notch 42) can vary depending on the application. For example,in some embodiments, notch 42 is “V-shaped” or “U-shaped”. These shapesare desirable because they allow notch 42 to substantially conform tothe outer surface of a medical device such as catheter 24. This mayimprove the ability for elevator 36 to securely hold the position ofcatheter 24.

In addition, the arrangement of ridges 40 and notch 42 can be reversed.For example, in some embodiments the “ridge” may be formed on theelevator, whereas the “notch” may be disposed on the medical device asdepicted in FIG. 2A. Here it can be seen that medical device 24′includes a channel or notch 40′. Elevator 36′ may be used with device24′, and elevator 36′ includes a ridge 42′ that is configured to matewith notch 40. This concept of altering the arrangement of ridges andnotches can be utilized for essentially any embodiment disclosed herein.

Another feature of assembly 10 is illustrated in FIG. 4. Here it can beseen that in addition to being able to hold the position of catheter 24,elevator 36 and ridges 40 on catheter 24 can function together like aratchet so that catheter 24 can be moved in a step-wise manner inopposing directions such as, for example, either in the proximal or thedistal direction. For example, allowing elevator 36 to move downward(e.g., by releasing tension on the elevator control wire) to position 36a applies a small amount of force onto ridge 40 a, thereby advancingcatheter 24 in the distal direction. Similarly, actuating elevator 36(e.g., by adding tension to the elevator control wire) applies forceonto ridge 40 b, thereby advancing catheter 24 in the proximaldirection. Once catheter 24 is moved in either direction and once thereis enough clearance over ridges 40, elevator 36 can “ratchet” back intoa position between two adjacent ridges 40. This once again secures theposition of catheter 24. If desired, additional ratchet steps can beperformed to move catheter 24 in either the proximal or distaldirection.

In some embodiments, catheter 24 may be an endoscopic guide catheter.However, catheter 24 need not necessarily be a guide catheter ascatheter 24 can be any suitable catheter or related medical device foruse with endoscopes. The use of catheter 24 may be similar to the use oftypical endoscopic catheters. For example, catheter 24 may be advancedthrough the working channel of an endoscope to a location adjacent anarea of interest. Catheter 24 may then be used for its intended purpose.For example, if catheter 24 is a guide catheter then another diagnosticor therapeutic medical device may be advanced over or through (i.e.,through a lumen defined therein) catheter 24.

Ridges 40 may be formed on catheter 24 in a number of different ways.For example, ridges 40 may be extruded onto catheter 24. Alternatively,ridges 40 may be adhesively bonded, welded, mechanically attached,brazed, or otherwise coupled to catheter 24 in any other suitable way.In some embodiments, ridges 40 may be formed on an adhesive-backed stripof material that can be adhered to catheter 24. This embodiment may bedesirable, because it allows ridges 40 to be added to essentially anycatheter suitable for use with an endoscope.

In some embodiments, ridges 40 may be made from a polymer material thatis attached to catheter 24 using any suitable method (such as thoselisted above). Some examples of suitable polymers may includepolytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE),fluorinated ethylene propylene (FEP), polyoxymethylene (POM, forexample, DELRIN® available from DuPont), polyether block ester,polyurethane, polypropylene (PP), polyvinylchloride (PVC),polyether-ester (for example, ARNITEL® available from DSM EngineeringPlastics), ether or ester based copolymers (for example,butylene/poly(alkylene ether) phthalate and/or other polyesterelastomers such as HYTREL® available from DuPont), polyamide (forexample, DURETHAN® available from Bayer or CRISTAMID® available from ElfAtochem), elastomeric polyamides, block polyamide/ethers, polyetherblock amide (PEBA, for example available under the trade name PEBAX®),ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE),Marlex high-density polyethylene, Marlex low-density polyethylene,linear low density polyethylene (for example REXELL®), polyester,polybutylene terephthalate (PBT), polyethylene terephthalate (PET),polytrimethylene terephthalate, polyethylene naphthalate (PEN),polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI),polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (for example, KEVLAR®), polysulfone,nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon),perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin,polystyrene, epoxy, polyvinylidene chloride (PVdC), polycarbonates,ionomers, biocompatible polymers, other suitable materials, or mixtures,combinations, copolymers thereof, polymer/metal composites, and thelike.

Alternatively, ridges 40 may be made from a metal, metal alloy,metal-polymer composite, or the like. Examples of suitable metals andmetal alloys include stainless steel, such as 304V, 304L, and 316LVstainless steel; mild steel; nickel-titanium alloy such aslinear-elastic or super-elastic nitinol, nickel-chromium alloy,nickel-chromium-iron alloy, cobalt alloy, tungsten or tungsten alloys,MP35-N (having a composition of about 35% Ni, 35% Co, 20% Cr, 9.75% Mo,a maximum 1% Fe, a maximum 1% Ti, a maximum 0.25% C, a maximum 0.15% Mn,and a maximum 0.15% Si), hastelloy, monel 400, inconel 825, or the like;other Co—Cr alloys; platinum enriched stainless steel; or other suitablematerial.

In some embodiments, ridges 40 may also be made from, doped with, orotherwise include a radiopaque material. Radiopaque materials areunderstood to be materials capable of producing a relatively brightimage on a fluoroscopy screen or another imaging technique during amedical procedure. This relatively bright image aids the user ofcatheter 24 in determining its location. Some examples of radiopaquematerials can include, but are not limited to, gold, platinum,molybdenum, palladium, tantalum, tungsten or tungsten alloy, plasticmaterial loaded with a radiopaque filler, and the like.

Another example medical device 324 is shown in FIG. 4A. Here it can beseen that ridges 340 define ring-like structures that extend arounddevice 324. Ridges 340 function much like ridges 40 and, consequently,can interact with elevator 36 in a similar manner. In some embodiments,a longitudinal ridge 340′, in addition to ridges 340, may be disposed ondevice 324′ as shown in FIG. 4B. Longitudinal ridge 340′ may extendalong the longitudinal axis of device 324′, and it may be configured tofit within elevator 36 in a manner that allows longitudinal movement ofdevice 324. Rotation of device 324′ so that longitudinal ridge 340′ is“disengaged” from elevator 36 allows ridges 340 to substantially securethe longitudinal position of device 324′ in essentially the same waythat ridges 40 secure the position of device 24.

FIG. 5 illustrates another example catheter 124 that is similar in formand function to catheter 24 except that ridges 140 on catheter 124 forma plurality of teeth or teeth-like projections. Teeth 140 are arrangedor spaced so that elevator 136 can be disposed between adjacent “fangs”.In addition, elevator 136 and teeth 140 can be ratcheted so thatcatheter 140 can be distally advanced or proximally retracted inaddition to being held in position. The steps and mechanism forratcheting teeth 140 is analogous to how ridges 40 are ratcheted.

FIG. 5 also depicts that elevator 136 may have a different shape andthat elevator 136 may be rotatable. These features may be desirable, forexample, because they may allow the orientation and/or position ofelevator 136 to be utilized to shift the position of device 124. Forexample, elevator 136 is shown to have a shape that resembles atriangle. The “points” 136 a/136 b/136 c of the triangle can pressagainst teeth 140 so that as elevator 136 is rotated in acounter-clockwise direction, one or more of points 136 a/136 b/136 c canengage teeth 140 in a manner that distally advances device 124.Conversely, clockwise rotation of elevator 136 may be utilized forretracting device 124. Other shapes are contemplated such asstar-shaped, polygonal-shaped, etc., that can be similarly used toachieve movement of device 124. Rotation of elevator 136 may becontrolled using conventional means such as with the use of a controlwire.

FIG. 6 illustrates another example catheter 224 that can be used with anendoscope. Catheter 224 includes a sliding needle apparatus 244 having aneedle 246 attached to a needle housing 248. A trigger 250 is alsoattached to housing 248. Sliding needle apparatus 244 is configured tointeract with elevator 36 so that needle 246 can be slid out fromcatheter 224. In some embodiments, elevator 36 is actuated so thatelevator 36 contacts catheter 224. Once in this position, catheter 224can be proximally retracted so that trigger 250 engages elevator 36.Catheter 224 can then be further retracted so that force is applied totrigger 250, causing trigger 250 to slide within catheter 224 untilneedle 246 emerges from the distal end of catheter 224 as shown in FIG.7.

In other embodiments, elevator 36 can press against and hold theposition of catheter 224. Then, elevator 36 can be lowered (e.g., byreleasing tension from the elevator control wire), thereby exerting adistal force on trigger 250. The force on trigger 250 slides needle 246distally out from catheter 224.

It can be appreciated that the interaction of elevator 36 with thevarious ridges can be utilized to carry out a number of additionalfunctions. For example, in some embodiments, needle 246 may extend outfrom catheter 224 and trigger 250 may act like a syringe plunger toadminister fluids, therapeutic or diagnostic agents, or any othersuitable material from needle 246. Alternatively, trigger 250 maycontrol a cutting device such as a clevis or clamp coupled to catheter224. Moreover, trigger 250 may control a visualization apparatus such asa camera. For example, trigger 250 may slide the camera out fromcatheter 224 or otherwise turn on or adjust the camera.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. The invention's scope is, of course, defined in the languagein which the appended claims are expressed.

1. An endoscopic instrument assembly, comprising: an endoscope having ahandle portion, a shaft portion, and a working channel formed in theshaft portion, the shaft portion having a distal end region; a distalport disposed at the distal end region; a medical device disposed in theworking channel, the medical device having one or more ridges formed onan outer surface thereof; and an elevator disposed adjacent the distalport, the elevator being configured to engage the one or more ridges. 2.The endoscopic instrument assembly of claim 1, wherein the medicaldevice is a catheter.
 3. The endoscopic instrument assembly of claim 1,wherein the ridges define a plurality of teeth on the outer surface ofthe catheter.
 4. The endoscopic instrument assembly of claim 1, whereinthe medical device includes a single ridge that defines a triggerattached to a needle assembly.
 5. The endoscopic instrument assembly ofclaim 1, wherein a notch is defined in the elevator.
 6. The endoscopicinstrument assembly of claim 5, wherein the shape of the elevatoradjacent the notch substantially conforms to the shape of the outersurface of the medical device.
 7. The endoscopic instrument assembly ofclaim 1, wherein the one or more ridges define one or more rings thatextend about the medical device.
 8. The endoscopic instrument assemblyof claim 7, further comprising a longitudinal ridge extending along alongitudinal axis of the medical device.
 9. The endoscopic instrumentassembly of claim 1, wherein the elevator is rotatable.
 10. A method ofusing an endoscopic instrument assembly, comprising the steps of:providing an endoscope having a working channel formed therein and anelevator; advancing the endoscope through a body lumen to a positionadjacent an area of interest; providing a catheter, the catheter havingan outer surface with one or more of ridges formed thereon; advancingthe catheter through the working channel to a position adjacent an areaof interest; and actuating the elevator.
 11. The method of claim 10,wherein the step of actuating the elevator includes bringing theelevator into contact with the catheter.
 12. The method of claim 10,wherein the step of bringing the elevator into contact with the catheterincludes disposing the elevator between a pair of adjacent ridges formedon the outer surface of the catheter.
 13. The method of claim 12,further comprising the step of re-actuating the elevator so that theelevator applies a force on one of the ridges and advance the catheterin the distal direction.
 14. The method of claim 12, further comprisingthe step of re-actuating the elevator so that the elevator applies aforce on one of the ridges and advance the catheter in the proximaldirection.
 15. The method of claim 10, wherein the catheter includes asingle ridge defining a needle trigger, and wherein the step ofproviding a catheter includes providing a catheter with a sliding needleformed therein.
 16. The method of claim 15, wherein the step ofactuating the elevator includes engaging the elevator with the needletrigger.
 17. The method of claim 16, wherein the step of engaging theelevator with the needle trigger slides the needle trigger and theneedle relative to the catheter and slides the needle out from thecatheter.
 18. The method of claim 16, further comprising the step ofproximally retracting the catheter while the elevator is engaged withthe needle trigger so that the needle slides out from the catheter. 19.The method of claim 10, further comprising the step of disposing aguidewire in the working channel.
 20. The method of claim 19, whereinthe step of actuating the elevator secures the position of the guidewirewithin the working channel.
 21. A catheter for use with an endoscope,the endoscope having a working channel formed therein and having anelevator, the catheter comprising: an elongate catheter shaft having anouter surface; and one or more ridges formed on the outer surface, theridges being spaced so that the endoscope elevator can be placedadjacent the one or more ridges to hold, advance, or retract thecatheter shaft within the working channel of the endoscope.
 22. Thecatheter of claim 21, wherein the one or more ridges define a pluralityof teeth on the outer surface of the catheter.
 23. The catheter of claim21, wherein a single ridge is formed on the outer surface of thecatheter and wherein the ridge defines a needle trigger.
 24. Thecatheter of claim 23, wherein the needle trigger is coupled to a needlehousing having a needle attached thereto, and wherein the needle housingis slidable relative to the catheter.
 25. An endoscopic instrumentassembly, comprising: an endoscope having a handle portion, a shaftportion, and a working channel formed in the shaft portion, the shaftportion having a distal end region; a distal port disposed at the distalend region; a medical device disposed in the working channel, themedical device having one or more notches formed on an outer surfacethereof; and an elevator disposed adjacent the distal port, the elevatorincluding a ridge configured to engage the one or more notches.